Using of Ice Cream for Diagnosis of Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Using of Ice Cream for Diagnosis of Diabetes Mellitus and Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854111
• Other study ID #: 08-55-03
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: October 3, 2016
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall global prevalence of type 2 diabetes mellitus (DM) is rising. Based on the latest Thai National Health Examination Survey, an estimated 3.2 million people had DM, of whom one-third was undiagnosed. The inexpensive oral glucose tolerance test (OGTT) is a more sensitive and reliable test of DM than fasting plasma glucose (FPG) or HbA1c, and is recommended for diagnosing DM and impaired glucose tolerance (IGT). Although the OGTT provides useful diagnostic information, poor patient tolerance of glucose solutions is inevitable.

Description:

Regarding the diagnosis of DM, oral glucose tolerance test (OGTT) identifies about 2% more individuals than does fasting plasma glucose (FPG). Hence OGTT is the method that has high sensitivity compared to other methods for diagnosis of IGT (impaired glucose tolerance) and diabetes. However, standard OGTT with 75-g glucose has poor patient tolerance and might cause reactive hypoglycemia. The alternatives for 75-g glucose would help for screening of DM with better tolerance. There were previous studies investigated substitutes for oral glucose solution with cookies and muffin. In the present study we hypothesized that an alternative food such as ice cream, a favorite dessert, can use for evaluation of the diagnosis of DM and IGT instead of standard 75-g glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteer

• agree to participate by written informed consent

Exclusion Criteria:

• previous history of diabetes mellitus

• pregnant woman

• hospitalised patients

• underlying disease of liver and kidney disease

• who take any medications that interfere with plasma glucose levels such as steroid

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• ice cream
The ice cream was made by nutritionists in Ramathibodi Hospital. It consisted of cornstarch, milk, sucrose, milk powder, egg yolk, and banana which contained carbohydrate 73.9 g, fat 27.7 g, protein 18.9 g for a total of 620.9 kcal with a cost of 35 bahts. The time for complete ingesting 75-g glucose and ice cream was 5 and 15 minutes, respectively.
• 75 g-glucose
The 75-g glucose is used for standard oral glucose tolerance test.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correct diagnosis of diabetes mellitus	We calculate the percentage of wrong diagnosis of diabetes mellitus when using ice cream instead of 75-g glucose (gold standard test). We also calculate sensitivity and specificity of ice cream test for diagnosis of diabetes mellitus.	2 hours
Secondary	The correct diagnosis of impaired glucose tolerance	We calculate the percentage of wrong diagnosis of impaired glucose tolerance using ice cream instead of 75-g glucose (gold standard test). We also calculate sensitivity and specificity of ice cream test for diagnosis of impaired glucose tolerance.	2 hours